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Prostate cancer, the number one urological cancer in Korea, continues to increase the number of patients every year due to rapid aging and Westernized dietary habits. Although prostate cancer initially responds effectively to androgen deprivation therapy (ADT), most patients progress to the castration-resistant stage after one to five years. At this stage, the cancer cells are not suppressed by hormone therapy and are difficult to cure.
Therefore, the medical community has recently emphasized the importance of early treatment with androgen receptor targeted agents (ARTAs) in hormone-sensitive prostate cancer (HSPC), a stage that precedes the progression to castration-resistant prostate cancer (CRPC).
Xtandi (enzalutamide) is an oral ARTA gaining traction in this treatment paradigm shift. Xtandi demonstrated a 61 percent reduction in the risk of imaging progression or death in the ARCHES phase 3 study in patients with mHSPC and is recommended as a combination therapy with ADT for treating hormone-sensitive metastatic prostate cancer in domestic and international guidelines.
Notably, starting Nov. 1, 2023, Xtandi was covered by health insurance in Korea for treating patients with hormone-sensitive metastatic prostate cancer (mHSPC), significantly improving patient access. In June 2024, the indication was expanded to biochemically recurrent high-risk hormone-sensitive nonmetastatic prostate cancer (High-risk BCR nmHSPC).
Korea Biomedical Review sat down with Professor Jeong Chang-wook of the Department of Urology at Seoul National University Hospital to learn more about the importance of early treatment of hormone-sensitive prostate cancer, the clinical benefits of Xtandi on the one-year anniversary of its coverage expansion, and how prescribing patterns have changed in real-world practice.
During a recent interview with Korea Biomedical Review, Professor Jeong Chang-wook of the Department of Urology at Seoul National University Hospital stressed the importance of early treatment for prostate cancer patients and the need to expand reimbursement for related therapies, including Xtandi.
Question: What are the characteristics of prostate cancer in Korea?
Answer: While prostate cancer is often perceived as a relatively benign cancer, it is a spectrum of cancers ranging from very benign to life-threatening. In particular, prostate cancer patients in Korea have a higher proportion of high-risk patients than in the West. Korean prostate cancers are often already advanced at the time of diagnosis and are characterized by a high degree of malignancy, even in cases with the same or similar characteristics. Ten to 15 percent of patients in Korea have metastases at first diagnosis, compared to only 5-6 percent in the United States.
Q: Why is the number of prostate cancer patients in their 40s and 50s increasing in Korea?
A: We don't know the exact reason, but we can speculate on two main reasons. The first is Westernized dietary habits, which have contributed to increased patient numbers. The second is that PSA (prostate-specific antigen) testing has become more prevalent, which has increased the number of cases detected.
Of course, there is still a big difference between the West and Korea regarding the frequency of PSA testing. While most men at risk of prostate cancer in the West, including the U.S., undergo PSA testing about once every two years, it is estimated that 80 percent of Korean men never undergo PSA testing in their lifetime.
Q: What is the five-year survival rate of prostate cancer in Korea by stage?
A: For locally advanced prostate cancer, the five-year survival rate is almost 99 percent. However, if there is metastasis, the five-year survival rate drops to about 50 percent. Early diagnosis using a PSA test is crucial to improve survival rates.
Q: What has changed since Xtandi was approved for hormone-sensitive metastatic prostate cancer in Korea?
A: First, international guidelines no longer recommend ADT alone, including luteinizing hormone releasing hormone (LHRH) agonists, in hormone-sensitive metastatic prostate cancer. Combination therapy with androgen receptor inhibitors (ARTAs) has long been the standard of care.
In Korea, it has been difficult to use ARTAs due to insurance reimbursement issues freely. Still, with the coverage of Xtandi for patients with hormone-sensitive metastatic cancer, it is now possible to establish a global standard of care in Korea.
In particular, prostate cancer is characterized by a decreased response rate to treatment once the disease progresses from the hormone-sensitive stage to the castration-resistant stage, and it is difficult to achieve a long survival period regardless of the treatment method. Therefore, how patients are treated in the hormone-sensitive stage from diagnosis determines their overall survival.
Previously, when ADT monotherapy was used in the hormone-sensitive phase, patients progressed to the castration-resistant phase after an average of 16 to 18 months. However, the aggressive use of ARTA combination therapies, including Xtandi, from the outset has extended that time to at least two to three years and has resulted in longer survival.
Professor Jeong Chang-wook
Q: What does “biochemical recurrence” (BCR) mean in the context of Xtandi's high-risk hormone-sensitive nonmetastatic prostate cancer indication, which was expanded last year, and what was the rationale behind the indication expansion?
A: Biochemical recurrence is when cancer cells are not seen on imaging tests after primary treatment, such as surgery or radiation, which is intended to be curative, but PSA test levels indicate recurrence. High-risk hormone-sensitive nonmetastatic prostate cancer that has biochemically recurred often has a rapid annual PSA increase of 0.75 ng/mL or more than 1 ng/mL, and even if no cancer cells are visible on imaging, it is likely that there is metastasis somewhere.
At this point, more aggressive treatment than radiation is needed, and the EMBARK study was initiated with the hypothesis that the addition of an ARTA, including Xtandi, rather than hormone blockade therapy alone, would delay the time to metastasis or castration-resistant stage and improve survival.
The study showed that patients with biochemically recurrent, high-risk, hormone-sensitive, nonmetastatic prostate cancer had a better outcome with Xtandi plus ADT (leuprolide) than with Xtandi alone or ADT alone, including a reduced risk of metastasis or death. Based on these clinical results, the indication was expanded to allow more men with prostate cancer in Korea to benefit from the treatment.
Q: In real-world practice, for which patients are Xtandi preferentially prescribed?
A: Because Xtandi is the only option indicated for all stages of prostate cancer, with or without metastasis, it can be used in all patients with prostate cancer, from hormone-sensitive prostate cancer to biochemical recurrence and beyond. It is one of the recommended first-line treatments for newly diagnosed metastatic hormone-sensitive prostate cancer, the preferred treatment before and after chemotherapy for castration-resistant prostate cancer, and the only licensed option for high-risk hormone-sensitive nonmetastatic prostate cancer that has biochemically recurred.
The main advantage of Xtandi in practice is that it can be used in elderly patients with underlying medical conditions, including diabetes, without significant side effects or quality of life concerns. It has also been shown to be effective in patients with low-risk or low-volume tumors, according to Evidence. In addition, Xtandi is more effective in patients with abdominal lymph nodes or lymph node metastases outside of the pelvic nodes.
Q: What should the domestic insurance coverage standards be improved for prostate cancer drugs?
A: The coverage of therapies used for prostate cancer seems to be later than for other cancers compared to the needs of patients. I would like to see this process be more proactive, as access to treatment is linked to patient survival and quality of life.
For example, Xtandi is covered for pre-chemotherapy in the hard-to-treat, high-risk stage of metastatic castration-resistant prostate cancer. Full coverage (mandatory coverage) is usually standardized at this stage for other cancers. Furthermore, since prostate cancer is a disease of older adults, many patients are not in a good financial situation, and full coverage seems necessary.
Patients with biochemically recurrent high-risk hormone-sensitive nonmetastatic prostate cancer can also use Xtandi due to an expanded indication last year, but it is not covered by insurance, making it a costly treatment despite being the only option.
Q: How can PSA testing in Korea be promoted for early detection of prostate cancer?
A: The best way is to include PSA testing in the National Cancer Screening Program. The PSA test is the most well-established and utilized tumor marker available. Unfortunately, despite being an efficient test that can screen patients with a simple blood test, it is still not included in the national cancer screening program.
Especially in Korea and Asia, PSA testing rates are lower than in Western countries, including the United States, so many patients are diagnosed with metastatic disease at the first test. As early diagnosis and treatment of prostate cancer has a significant impact on the prognosis, I hope that PSA testing can be reinvigorated in Korea to detect the disease early.
Q: How should we approach the long-term management of prostate cancer patients?
A: The management direction is slightly different depending on the patient's condition. For example, prostate cancer patients with metastasis need to continue hormone suppression therapy, so they need to be carefully monitored to manage side effects and complications.
In the localized stage of prostate cancer, surgery or radiation therapy can cause physical and functional adverse events, such as urinary incontinence, erectile dysfunction, and blood and stool changes, due to radiation toxicity. In this respect, it is necessary to manage the quality of life carefully, considering the long survival period.
Q: You are currently the Korean Society of Medical Robotics president. What are some of your recent projects?
A: The Korean Society of Medical Robotics is a multidisciplinary society that brings together doctors, engineers, and various industry people interested in medical robots. Within the society, there have been quite a few cases of new medical technologies or medical robots being developed and commercialized.
In particular, data-related technologies, such as data-driven surgical optimization, are evolving rapidly these days, and there is a lot of interest in data platforms and various AI technologies that can be used in the operating room.
As the shortage of medical personnel, including essential medical fields, has become more severe due to the ongoing healthcare turmoil, the development of related technologies, such as creating a surgical environment that collaborates with robots, is also actively planned to overcome this problem.
Q: What is your message to prostate cancer patients and their caregivers in Korea?
A: If prostate cancer is not detected early through active diagnosis, it is often more malignant and difficult to treat than we usually think. However, even in such cases, medical professionals and others continue working on new treatments, so please do not lose hope and continue to treat actively.
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